MAUDE Adverse Event Report: SYNTHES USA PRODUCTS LLC, 3.5MM LCP T-PLATE 4H HEAD/ 4H SHAFT/56MM-RIGHT ANGLE; APPLIANCE,FIXATION,NAIL

Model Number	241.141
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial surgery was in (b)(6) 2017 but actual day is unknown complainant part is not expected to be returned for manufacturer review/investigation, as part remains with the facility.Patient code (b)(4) used to capture: medical device hardware removal was performed due to soft tissue irritation.A review of the device history records has been requested and is currently pending completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2017 that hardware removal was performed due to soft tissue irritation.One 3.5mm lcp t-plate 4h head/4h shaft/56mm-right angle, one 2.7mm/3.5mm lcp lateral distal fibula plate 3h/right/73mm, eight 3.5mm cortex screws, one 3.5mm locking screw, and four 2.7mm locking screws were removed.Initial surgery was in (b)(6) 2017 but actual day is unknown.All parts were removed without any issues and intact.Removal surgery was completed successfully without any new implantation and patient status was satisfactory.This complaint involves 5 parts, this report is 1 of 5 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 241.141, lot# 7721572.Manufacturing location: (b)(4), manufacturing date: jun 25, 2014.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm lcp t-plate 4h head/4h shaft/56mm-right angle product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM LCP T-PLATE 4H HEAD/ 4H SHAFT/56MM-RIGHT ANGLE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES USA PRODUCTS LLC,; 1302 wrights lane east; west chester 19380
• MDR Report Key: 7210410
• Report Number: 2939274-2018-50365
• Device Sequence Number: 1157772
• Product Code: KTT
• UDI-Device Identifier: 10886982165954
• UDI-Public: (01)10886982165954(10)7721572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 241.141
• Device Catalogue Number: 241.141
• Device Lot Number: 7721572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR